Lyons, New Jersey 07939


Purpose:

When Veterans with Parkinson's disease (PD) suffer from depression, they are more likely to experience disease complications, interpersonal difficulties with caregivers, and poorer quality of life. Unfortunately, depression in Veterans with PD is inadequately treated at the current time. Treatment for depressed Veterans with PD will require the elimination of geographical barriers to care and approaches that address the unique aspects of PD. The proposed study will be the first to explore a novel and innovative, PD-informed psychotherapy package for depressed Veterans with PD and their Caregivers, delivered through video-to-home telehealth. If the results of this proposal are promising, a much needed treatment can be made available to Veterans with PD and their Caregivers across the country, regardless of geographical location.


Study summary:

Objective: There is a critical need for treatments that address depression and barriers to mental health care among the nearly 100,000 Veterans with Parkinson's Disease (PD) served by the VA. Depression in PD (dPD) is a major complicating factor in the movement disorder, affecting several key functional outcomes such as motor disability, cognitive status, quality of life, and caregiving relationships. The challenge to meeting the treatment needs of Veterans with dPD centers on the lack of clinicians who are knowledgeable about the interactions of PD and depression, the considerable transportation barriers faced by this population, combined with the geographical dispersion of specialized services within the VA, and the paucity of effectiveness research that informs treatments for dPD. The proposed study seeks to overcome these challenges by using a telehealth delivery platform (i.e., video-to-home) to test the effectiveness of a 10-session cognitive-behavioral treatment (CBT) package that has been tailored to address the unique needs of depressed Veterans with PD. The proposed treatment package also provides support and skills-training to the Veteran's Caregiver (3 sessions). This HSR&D proposal will be the first to: 1) to evaluate the effectiveness of TH-CBT for improving Veteran outcomes in dPD, 2) to examine the impact of TH-CBT for dPD on a variety of Caregiver outcomes, and 3) to assess Veteran and Caregiver perspectives on TH-CBT using a mixed-methods sequential explanatory design. Method: A PD-informed, telehealth-administered cognitive behavioral therapy package (TH-CBT) for dPD will be evaluated in a clinical effectiveness trial. 180 participants (90 Veterans and 90 Caregivers) will be enrolled. Half of the sample will receive the study treatment package (TH-CBT), in addition to their standard medical care. The other half will only receive standard medical care. The two groups will be compared at baseline, midpoint (week 5), endpoint (week 10), and 1 and 6 months post treatment. Veterans will be assessed with standard measures of depression, anxiety, quality of life, and motor function, while Caregivers will be evaluated with measures of caregiver burden, empowerment, and communication. Impact: Given the public health impact of improved depression treatment in Veterans with Parkinson's disease, the knowledge to be gained may be significant and the project could directly impact clinical practice. The data gleaned from this study will guide the wide-scale implementation of this remote care model within the VA for meeting the specialized needs of Veterans with PD. Towards this goal, successful results for the proposed study will facilitate a multisite initiative to further examine issues of dissemination, implementation, and effectiveness, using a hybrid research design. Ultimately, these HSR&D data may support the development of a centralized care model, in which highly specialized dPD providers, concentrated in a few locations, provide specialty care to Veterans and Caregivers across the country.


Criteria:

Inclusion Criteria: - Confirmed PD diagnosis in the VA medical record - Primary Major Depression, Dysthymia, or Depression NOS of at least moderate severity per the SCID - Access to a computer/tablet with high-speed internet access. primary - Ages 35-85 - Stable medication and mental health regimen greater than or equal to 6 weeks, including: - applicable antidepressants - other psychotropic agents - movement disorder drugs - clinic-based psychotherapies - Willingness to involve a family member or friend to participate Exclusion Criteria: - Possible dementia or marked cognitive impairment [Montreal Cognitive - Assessment Score (MoCA) less than 21 - Motor fluctuations greater than or equal to 50% of the day - Suicidal plans or intent (determined by clinical interview) - Unstable medical conditions


NCT ID:

NCT02475954


Primary Contact:

Principal Investigator
Alejandro Interian, PhD
Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ

Alejandro Interian, PhD
Phone: (908) 647-0180 ext. 4617
Email: alejandro.interian@va.gov


Backup Contact:

Email: dobkinro@rutgers.edu
Roseanne Dobkin, PhD
Phone: (732) 235-4051


Location Contact:

Lyons, New Jersey 07939
United States

Alejandro Interian, PhD
Phone: 908-647-0180
Email: alejandro.interian@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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